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CompletedNCT00164411Updated Mar 14, 2012

Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine

A Phase 1 interventional study of Tetanus-diphtheria toxoids (Td) and 7-valent pneumococcal conjugate vaccine in Pneumococcal Infections, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Open to participants aged 50 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-14.

Sponsored by Centers for Disease Control and Prevention · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 64 Years
Sex
All
01

Study summary

The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination ("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more effective without causing too many side effects.

Read the detailed description

The only vaccine licensed in the United States for protecting adults against pneumococcal disease (PPV23) protects against invasive disease in observational studies but has generally been poorly effective against pneumonia or all-cause mortality in randomized clinical trials. Another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid (PCV7) is licensed for children and under investigation in adults.

In this pilot study, we are comparing the safety and immunogenicity of three immunization schedules in adults:

  • Td vaccine, 2-week interval, PCV7, 4-month interval, PPV23
  • PCV7, 4-month interval, PPV23
  • PPV23

We aim to:

  • compare the safety profiles of pneumococcal vaccines given on each of the three schedules
  • compare serotype-specific ELISA antibody response to pneumococcal antigens given on each of the three schedules
  • compare functional serotype-specific antibody responses to pneumococcal antigens given on each of the three schedules
  • study the influence of diphtheria antibody levels at the time of pneumococcal conjugate vaccine administration on the magnitude of the immune response to pneumococcal antigens
02

Conditions studied

  • Pneumococcal Infections

Keywords

  • Diptheria-Tetanus vaccine
  • Pneumococcal vaccine
  • Adverse events following vaccination
  • Immunization
  • Immunogenicity
03

In context

Pneumococcal Infections

286 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 30 is below the median of 365 across 234 interventional studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Exclusion Criteria:

  • Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start
  • Any vaccination within 2 weeks prior to first study vaccine
  • Evidence of systemic or local infection within one week prior to first study vaccine
  • HIV infection
  • Renal failure
  • Receipt of a pneumococcal or Td vaccine within 5 years
  • Current receipt of therapy for neoplastic disease
  • Current receipt of immunosuppressive therapy
  • Terminal illness withlife expectancy less than 3 months
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
30 participants

Interventions

06

What researchers measure

Primary outcomes

  1. ELISA for S. pneumoniae antibody 2 months after receiving PPV23

  2. Functional S. pneumoniae antibody 2 months after receiving PPV23

Secondary outcomes

  1. Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination

07

Study locations

1 site
  • Emory University School of Medicine
    Atlanta, Georgia 30322, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00164411
Collaborators
Emory University
First posted
Sep 14, 2005
Start date
Jan 2004
Completion
Mar 2005
Last update
Mar 14, 2012

Study contacts

Harry L Keyserling, MD
principal investigator · Emory University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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